Trump to pitch national PDMP to fight opioid crisis

The president will visit New Hampshire to announce a slate of proposals, including calling for legislation to allow Medicaid to reimburse residential treatment at facilities with more than 16 beds.

By David Lim • March 19, 2018

Prescribed Reading: Neuro's comeback tour

Activity in the neuroscience space spiked higher, with a flurry of licensing deals highlighting BioPharma Dive's prediction the field is ready for a resurgence.

By Lisa LaMotta • March 16, 2018

Solid Biosciences reveals upgraded clinical hold for gene therapy

The newly public biotech lost more than 60% of its value after announcing an FDA hold for its DMD study. 

By Lisa LaMotta • March 15, 2018

Pharma pay to hospitals in 340B under fire at Senate panel

The hearing comes as drugmakers point fingers at hospitals and other players involved in the drug pricing system.

By David Lim • March 15, 2018

SEC charges against Theranos, Holmes dispel last shreds of unicorn myth

According to the SEC's complaint, both repeatedly misled investors about the state of the company's once widely touted blood-testing technology. 

By Ned Pagliarulo • March 15, 2018

MorphoSys readies filing after positive Phase 2 lymphoma data

Promising mid-stage data in a hard-to-treat patient population has prompted the biotech to seek FDA approval early and begin commercialization plans.

By Lisa LaMotta • March 14, 2018

Right to Try fails amid warning from regulators, patient groups

Backers of the bill like President Trump and the Koch brothers faced off against major patient groups and some regulators.

By David Lim • March 14, 2018

Advaxis drops after clinical hold due to patient death

The death led the FDA to halt enrollment and dosing in a trial testing Advaxis' drug with Imfinzi, but analysts suggest AstraZeneca's drug could be the culprit.

By Lisa LaMotta • March 13, 2018

Prescribed Reading: Bold comments from Gottlieb, PBMs get the spotlight

Against the backdrop of Cigna's planned deal to buy Express Scripts, the FDA chief sharply criticized bad behavior from players involved in drug pricing.

By Lisa LaMotta • March 9, 2018

FDA recognizes GMP inspections by 4 more EU states

The move expands the number of EU regulators the FDA says can reliably conduct inspections of drug manufacturing facilities to 12.

By Ned Pagliarulo • March 8, 2018

Gottlieb takes aim at payers, pharmas for blocking biosimilars

The FDA chief lambasted PBMs, insurers and branded drugmakers for allegedly blocking market entry of the copycat biologics.

By Lisa LaMotta , David Lim • March 8, 2018

TaiMed's HIV biologic secures FDA nod

The approval showcases how China-based manufacturers of biologic drugs are moving up value chains to produce novel drugs. 

By Randi Hernandez • March 7, 2018

23andMe's DTC cancer test tentatively OK'd by FDA

Take-home genetic tests have gained traction with consumers, but regulators are warning they're no substitute for screenings at the doctor's office.

By Jacob Bell • March 7, 2018

Opdivo gets more flexible dosing, gaining edge over competition

The big pharma has found a new way to differentiate its PD-1 inhibitor as its closest competitor makes up ground.

By Lisa LaMotta • March 6, 2018

What's 'BerkshAmazMorgan' really capable of?

The recent announcement by Berkshire Hathaway, Amazon and JPMorgan Chase has pharma wondering what will happen next. Here are our top 4 predictions for this new collaboration.

By Howard Deutsch • March 6, 2018

Numbers show drugmakers are keeping RTFs under wraps

A BioPharma Dive analysis of company and FDA data show plenty of companies are not disclosing Refusal to File letters from the FDA. 

By Lisa LaMotta • March 5, 2018

Senator questions big pharma buyback strategy

Minnesota Senator Tina Smith asked five top pharmaceutical companies whether the benefits from the recent tax cut would be used to help lower drug costs.

By Randi Hernandez • March 5, 2018

Biogen, AbbVie withdraw MS drug after safety signals

The two companies removed Zinbryta, a third-line MS treatment, from global markets after cases of encephalitis cropped up. 

By Randi Hernandez • March 2, 2018

Trump backs lawsuit against opioid companies

Bipartisan lawmakers are also working on a bill allowing more physicians to prescribe medication-assisted treatment and a restriction on prescriptions.

By David Lim • March 2, 2018

Prescribed Reading: Sketchy subgroup analyses, puzzling probes

Several companies used creative thinking when evaluating clinical trial results, while others played the game of excluding details when informing investors.

By Lisa LaMotta • March 2, 2018

Allergan's Esmya delayed in US amid EU liver injury cases

While details from Allergan are scarce, the FDA has pushed back Esmya's target action date to late summer.

By Lisa LaMotta • March 1, 2018

Portola investors are sick of AndexXa delays

FDA feedback indicates Portola will have to run another clinical trial for its reversal agent, likely postponing the drug's market entry even further.

By Jacob Bell • March 1, 2018

Benzo overprescribing risk may be overlooked amid opioid crisis

A new commentary in the New England Journal of Medicine argues for greater monitoring and physician education around benzodiazepine use.

By Ned Pagliarulo • Feb. 28, 2018

Collegium warned for opioid drug marketing

The company was hit with a warning letter from the FDA after failing to prominently disclose the risks of the drug at a recent conference. 

By Jacob Bell • Feb. 28, 2018

Celgene's ozanimod hit with Refusal to File in latest setback

The agency's decision not to accept the NDA for the MS drug puts billions in potential revenue at stake. 

By Lisa LaMotta • Feb. 28, 2018